A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Start Date
9/1/2023
Completion Date
6/30/2028
Summary
Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.
Detailed Description
This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; \<6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control. In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will have implemented the TLC. All sites enroll for the entire 45 months and thus contribute patients to both the control and TLC groups. There are an equal number of TLC and control intervals; thus approximately 500 patients will be in each group. Participant follow-up will occur by telephone at 30 and 90 days after discharge.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Transitional Liver Clinic (TLC)
Conditions
Locations
University of Chicago
Chicago, Illinois 60637
United States
Indiana University Division of Gastroenterolgy and Hepatology
Indianapolis, Indiana 46202
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania 19141
United States